You can add Onconova Therapeutics to the lineup of biotechs preparing to jump through the newly opened IPO window. The biotech filed an S-1 late last week looking to raise $75 million for its cancer drug pipeline. And it's looking for some positive attention as a slate of four biotechs prepares to go public later this week.
Most of Onconova's eggs are in a single basket--the ambitious program for the late-stage cancer drug rigosertib. Last summer the biotech announced that it had rounded up a $50 million commitment from its venture backers. And just weeks later Baxter stepped up with a $50 million upfront to snag the European rights to the drug, a multikinase inhibitor targeting mitotic and PI-3 kinase pathways.
One study involves an IV formulation of rigosertib for patients with myelodysplastic syndromes while a Phase II/III is underway for pancreatic cancer and an early-stage study focuses on acute myelogenous leukemia.
In its SEC filing, Onconova noted that investigators had enrolled 270 patients in the lead trial in May 2013 and expect to report top-line overall survival results later this year or in Q1 2014.In the Phase I/II study, 30 evaluable MDS patients, researchers said they tracked objective responses in 12 patients, five of which were complete bone marrow responses.
"To our knowledge, there are no other current Phase III trials in this patient population, reported the company. "If we achieve positive results in this trial, we intend to submit a New Drug Application, or NDA, to the FDA in the second half of 2014, and a Marketing Authorization Application, or MAA, to the European Medicines Agency, or the EMA, by the fourth quarter of 2014 or the first quarter of 2015 for marketing approval of rigosertib IV."
The IPO window essentially closed for biotechs after the 2008 financial crisis but opened decisively at the beginning of this year. Many of these IPOs have been doing very well, encouraging more companies to come in off the sidelines while investors seem ready to gamble on drug development once again. This week alone, bluebird bio is expected to go public alongside Regado, Aratana and PTC Therapeutics.